NCT04429906

Diagnostic Study of Huami Smart Wearable Device

Evaluation of Accuracy of Blood Oxygen Saturation Detection Function of Huami Smart Wearable Device

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a cross-sectional diagnostic study. In this study, wrist oxygen saturation (SwO2) will be measured by Huami smart wearable device, SpO2 of pulse oxygen saturation monitor with medical device registration certificate and SaO2 of arterial blood gas analysis will be used as reference values. A total of 180 group data will be measured in 30\~50 patients with SaO2/ SpO2 between 80%∽100%. The investigators aim to evaluate the accuracy of blood oxygen saturation detection function of huami smart wearable device.

Detailed description

This is a cross-sectional diagnostic study. 30\~50 inpatient aged 18～85y with SaO2/ SpO2 between 80%∽100% will be recruited from the Department of Respiratory and Critical Care of Peking University First Hospital. 180 group data ( 37 of SaO2/ SpO2 between 80%∽90%, 143 of SaO2/ SpO2 between 90%∽100%) will be measured, with an average of 4-6 groups per patient. Some clinical information such as demographic data, laboratory tests, comorbidity, smoking habit and will be collected. Patients have their pulse oximetry measured multiple times using a pulse oximeter/tabletop electrocardiograph with a medical device registration certificate, and arterial blood gas analysis will be performed if required. While monitoring the pulse oximetry, a Huami smart wearable device is worn on the ipsilateral wrist to determine blood oxygen saturation. Primary outcome is the wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference.. The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2020-114). Any protocol modifications will be submitted for the IRB review and approval.

Conditions

• Oxygen Saturation

Interventions

Type	Name	Description
DEVICE	Huami smart wearable device	Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.

Timeline

• Start date: 2020-05-29
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2020-06-12
• Last updated: 2020-06-12

Locations

1 site across 1 country: China